Table 2.
Patient baseline characteristics from the 9 randomized controlled trials included in this study, and from which data were analyzed and reported by the other 7 post-hoc studies included in this study.
| Characteristics | DELIVER (N = 6,263) | EMPERIAL-Preserved (N = 315) | PRESERVED-HF (N = 324) | EMPEROR-Preserved (N = 5,988) | CANONICAL (N = 82) | SCORED (N = 10,584) | SOLOIST-WHF (N = 1,222) | VERTIS CV (N = 8,246) | DECLARE-TIMI 58 (N = 17,160) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Comparison | Drug | Placebo | Drug | Placebo | Drug | Placebo | Drug | Placebo | Drug | Standard diabetic therapy | Drug | Placebo | Drug | Placebo | Drug | Placebo | Drug | Placebo |
| Number of patients | 3,131 | 3,132 | 157 | 158 | 162 | 162 | 2,997 | 2,991 | 42 | 40 | 5,292 | 5,292 | 608 | 614 | 680 a | 327 a | 8,582 | 8,578 |
| Mean ± SD or median (IQR) age (years) | 71.8 ± 9.6 | 71.5 ± 9.5 | 74 (68–79) | 75 (68–81) | 69 (64–77) | 71 (63–78) | 71.8 ± 9.3 | 71.9 ± 9.6 | 76.5 ± 6.4 | 75.9 ± 5.8 | 69 (63–74) | 69 (63–74) | 69 (63–76) | 70 (64–76) | 63.8 ± 8.3 | 64.7 ± 8.2 | 63.9 ± 6.8 | 64.0 ± 6.8 |
| Female, n (%) | 1,364 (43.6%) | 1,383 (44.2%) | 70 (44.6%) | 66 (41.8%) | 92 (56.8%) | 92 (56.8%) | 1,338 (44.7%) | 1,338 (44.6%) | NA (33.3%) | NA (32.5%) | 2,347 (44.3%) | 2,407 (45.5%) | 198 (32.6%) | 214 (34.9%) | NA (34.4%) | NA (36.7%) | 3,171 (36.9%) | 3,251 (37.9%) |
| Mean ± SD or median (IQR) BMI (kg/m2) | 29.8 ± 6.2 | 29.9 ± 6.1 | 30.1 (26.5–34.2) | 28.8 (26.1–32.8) | 35.1 (30.4–41.8) | 34.6 (29.7–40.4) | 29.77 ± 5.8 | 29.90 ± 5.9 | 24.7 ± 3.6 | 25.2 ± 3.7 | 31.9 (28.1–36.2) | 31.7 (28.0–36.1) | 30.4 (26.3–34.3) | 31.1 (27.3–34.5) | 32.6 ± 5.3 | 32.9 ± 5.3 | 32.1 ± 6.0 | 32.0 ± 6.1 |
| NYHA functional class, n (%) | ||||||||||||||||||
| I-II | 2,314 (73.9%) | 2,399 (76.6%) | 117 (74.5%) | 126 (79.7%) | 96 (59.3%) | 90 (55.6%) | 2,435 (81.2%) | 2,452 (82.0%) | 88.10% | 95.0% | 89.6% | 93.3% | ||||||
| III-IV | 817 (26.1%) | 732 (23.4%) | 39 (24.8%) | 32 (20.3%) | 65 (40.1%) | 72 (44.4%) | 562 (18.8%) | 539 (18.0%) | 11.90% | 5.0% | 7.2% | 4.6% | ||||||
| Mean ± SD or median (IQR) LVEF (%) | 54.0 ± 8.6 | 54.3 ± 8.9 | 53 (45–58) | 53 (46–59) | 60 (55–65) | 60 (54–65) | 54.3 ± 8.8 | 54.3 ± 8.8 | 61.1 ± 7.8 | 61.9 ± 7.6 | 60 (51–64) | 60 (51–65) | 35 (28–47) | 35 (28–45) | ||||
| Median (IQR) NT-ProBNP, pg./ml | 966 (572–1,653) | 843 (407–1,913) | 641 (373–1,210) | 710 (329–1,449) | 994 (501–1,740) | 946 (498–1,725) | 196 (75–565) | 198 (75–561) | 1,817 (855–3,659) | 1,741 (843–3,582) | ||||||||
| Diabetes mellitus, n (%) | 1,401 (44.7%) | 1,405 (44.9%) | 86 (54.8%) | 75 (47.5%) | 90 (55.6%) | 91 (56.2%) | 1,466 (48.9%) | 1,472 (49.2%) | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% |
| Mean ± SD or median (IQR) eGFR (mL/min/1.73 m2) | 61 ± 19 | 61 ± 19 | 54.5 (41–70) | 58.5 (44–71.5) | 56 (42–69) | 54 (41–69) | 60.6 ± 19.8 | 60.6 ± 19.9 | 57.8 ± 14.2 | 56.0 ± 13.8 | 44.4 (37–51.3) | 44.7 (37–51.5) | 49.2 (39.5–61.2) | 50.5 (40.5–64.6) | 85.4 ± 15.8 | 85.1 ± 16.0 | ||
Data from HFmrEF or HFpEF population. Abbreviations: BMI, body mass index; CANONICAL, CANagliflOziN heart faIlure with preserved ejection fraCtion study for type 2 diAbetes meLlitus trial; DECLARE-TIMI 58, Dapagliflozin Effect on CardiovascuLAR Events trial; DELIVER, Dapagliflozin Evaluation to improve the LIVEs of patients with pReserved ejection fraction heart failure trial; eGFR, estimated glomerular filtration rate; EMPERIAL-Preserved, effect of EMPagliflozin on ExeRcise ability and heart failure symptoms In patients with chronic heArt faiLure trial; EMPEROR-Preserved, EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction trial; IQR, interquartile range; LVEF, left ventricular ejection fraction; NA, not available; NT-ProBNP, N-terminal pro B-type natriuretic peptide; NYHA, New York Heart Association; PRESERVED-HF, dapagliflozin in PRESERVED ejection fraction Heart Failure trial; SCORED, effect of Sotagliflozin on CardiOvascular and Renal Events in patients with type 2 Diabetes and moderate renal impairment who are at cardiovascular risk trial; SD, standard deviation; SOLOIST-WHF, effect of SOtagLiflOzin on cardiovascular events In patientS with Type 2 diabetes post Worsening Heart Failure trial; VERTIS CV, eValuation of ERTugliflozin effIcacy and Safety CardioVascular outcomes trial.